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Cervical CancerPhase 2NCT07363330

A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer

A Phase 2 study testing Utidelone plus Toripalimab in people with Cervical Cancer and Recurrent, run by Zhongnan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase II clinical trial to evaluate the safety and efficacy of Utidelone, a genetically engineered epothilone derivative, combined with Toripalimab, a PD-1 inhibitor, in patients with recurrent or metastatic cervical cancer who have progressed after standard treatments. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer, Recurrent, Metastatic
What is being tested?
Utidelone plus Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
1 Feb 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent: Patients must voluntarily sign an informed consent form prior to any study-related procedures.
  • Age: Aged ≥18 years and ≤75 years.
  • Diagnosis: Histologically or cytologically confirmed recurrent or metastatic cervical carcinoma.
  • Performance Status: With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Measurable Disease: With at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Prior Therapy:
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  • Patients must have received at least one line of standard systemic chemotherapy for recurrent/metastatic disease, OR
  • Patients with rapid disease progression (occurring within 6 months) during or after prior neoadjuvant or concurrent chemoradiotherapy.
  • Treatment-Related Toxicity: Recovery from all toxicities related to prior anti-cancer therapies to ≤ Grade 1 (according to CTCAE v5.0). Patients with alopecia of any grade are eligible.
  • Adequate Hematological Function (within 1 week prior to enrollment, per local laboratory reference ranges):
  • White blood cell count (WBC) ≥ 2.5 × 10⁹/L.
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.
  • Platelet count (PLT) ≥ 100 × 10⁹/L.
  • Hemoglobin (Hb) ≥ 9.0 g/dL (transfusion or erythropoietin use is permitted to meet this criterion).
  • Adequate Liver and Kidney Functions (within 1 week prior to enrollment, per local laboratory reference ranges):
  • Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases).
  • Calculated creatinine clearance (Ccr) ≥ 60 mL/min.
  • Contraception: Patients of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days after the last dose of study treatment. A negative serum or urine pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment.
  • Life Expectancy: Anticipated life expectancy of at least 12 weeks.
  • Compliance: Patients must be able and willing to comply with the study protocol for treatment and follow-up.

Who cannot join

  • Concurrent Malignancy: History of other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin.
  • Recent Anti-cancer Therapy: Any anti-cancer therapy (including chemotherapy, radical radiotherapy, hormonal therapy, biological therapy, or anti-cancer Chinese herbal medicine) within 4 weeks prior to the initiation of study treatment.
  • Recent Major Surgery/Trauma: Major surgical procedure (excluding diagnostic biopsy) or significant traumatic injury within 4 weeks prior to the first dose of study drug, or anticipation of the need for major surgery during the study period.
  • Prior Neurotoxicity: History of ≥ Grade 3 neurological adverse reactions attributed to prior anti-microtubule therapy.
  • Symptomatic CNS Metastases: Patients with symptomatic central nervous system (CNS) metastases.
  • Pregnancy/Lactation: Women who are pregnant or breastfeeding.
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  • Hypersensitivity: Known or suspected hypersensitivity to any component of the study drugs or their excipients.
  • Severe Comorbidities: Any uncontrolled or severe concurrent medical condition that, in the investigator's judgment, would preclude participation, including but not limited to:
  • Severe cardiovascular or cerebrovascular disease.
  • Uncontrolled diabetes mellitus or hypertension.
  • Active severe infection.
  • Active peptic ulcer disease.
  • Uncontrolled psychiatric illness/disorder.
  • General Exclusion: Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or compliance, or make the patient unsuitable for study participation.
  • Contraindication to Steroids: Conditions for which corticosteroid use is contraindicated.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Qiu, PhD contact

18986255160

qiuhuiznyy@whu.edu.cn

China1 site

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Hui Qiu, PhD, 18986255160, qiuhuiznyy@whu.edu.cn

Other trials in China

About this study

Official title: Utidelone Combined With Toripalimab in Patients With Pretreated Recurrent or Metastatic Cervical Cancers: a Single-Arm, Phase II Study

This is a Phase II clinical trial to evaluate the safety and efficacy of Utidelone, a genetically engineered epothilone derivative, combined with Toripalimab, a PD-1 inhibitor, in patients with recurrent or metastatic cervical cancer who have progressed after standard treatments. The study will also assess the safety profile of this combination therapy. The primary objectives of this study include: (1) to determine the objective response rate (ORR), meaning whether the treatment can reduce the size of tumors or make them disappear, according to the RECIST 1.1 criteria; (2) to evaluate the safety of the treatment and document the side effects experienced by participants. This study is for individuals who: (1) are between 18 and 75 years old; (2) have a confirmed diagnosis of recurrent or metastatic cervical cancer; (3) have previously received at least one standard chemotherapy regimen that is no longer controlling the cancer; (4) are in generally good health, as determined by the study investigators. In this single-arm study, all participants will receive the same treatment: Utidelone will be administered by intravenous (IV) infusion over 1.5 hours, once a day for 5 consecutive days, in each 21-day treatment cycle; Toripalimab will be administered by IV infusion over 1.5 hours, once on Day 6 of each 21-day cycle. Participants may continue receiving the study drugs as long as they are benefiting from the treatment and side effects are manageable. Doctors will assess tumor size using imaging scans (like CT or MRI) every 6 weeks to monitor how the cancer responds to treatment. The study will take place at Zhongnan Hospital of Wuhan University and plans to include approximately 32 participants.

Being tested
Utidelone plus Toripalimab
Keywords
cervical cancer, recurrent / metastatic, Utidelone, Toripalimab, phase Ⅱ trial
Medical subject headings
Uterine Cervical Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Utidelone plus ToripalimabDrug

    1. Drug: Utidelone (1)Dosage: 30 mg/m² (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered once daily on Days 1-5 of each cycle. (4)Cycle Duration: 21 days (q3w).
    2. Drug: Toripalimab (1)Dosage: 240 mg (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered on Day 6 of each cycle. (4)Cycle Duration: 21 days (q3w).
Study groups in NCT07363330
Study groupRoleWhat they receive
Utidelone plus ToripalimabExperimental1. Drug: Utidelone (1)Dosage: 30 mg/m² (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered once daily on Days 1-5 of each cycle. (4)Cycle Duration: 21 days (q3w). 2. Drug: Toripalimab (1)Dosage: 240 mg (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered on Day 6 of each cycle. (4)Cycle Duration: 21 days (q3w).
Receives: Drug: Utidelone plus Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Measured: Tumor assessments are performed at baseline and every 6 weeks (± 3 days) until progression or start of new therapy. ORR is analyzed after all patients have completed at least 18 weeks of follow-up or experienced a study endpoint event.

Secondary outcomes (7)

  1. Progression-Free Survival (PFS)

    Measured: From the date of enrollment until first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first, assessed up to approximately 24 months.

  2. Time to Response (TTR)

    Measured: From the date of enrollment to the first documented objective response (Complete or Partial Response per RECIST 1.1), assessed up to approximately 24 months.

  3. Duration of Response (DoR)

    Measured: From the date of first documented objective response (CR or PR) until documented disease progression or death due to underlying cervical cancer, assessed up to approximately 36 months.

  4. Overall Survival (OS)

    Measured: From the date of enrollment until death from any cause, assessed up to approximately 36 months.

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Measured: From the first dose of study drug until 30 days after the last dose, assessed throughout the treatment period (up to approximately 24 months).

  6. Incidence of Serious Adverse Events (SAEs)

    Measured: From the first dose of study drug until 90 days after the last dose, assessed throughout the treatment and extended safety follow-up period (up to approximately 27 months).

  7. Number of Participants With Clinically Significant Laboratory Abnormalities

    Measured: Laboratory parameters are monitored at each 21-day treatment cycle from first dose until 30 days after the last dose (up to approximately 24 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363330
Sponsor's protocol ID
2025LCYJZX-ZD005
Status last verified
Dec 2025
First submitted
15 Jan 2026
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qiao G, Liu Z, Ding H, Lu H, Lin F, Shi Y, Zheng L, Wang M, Chen Y, Deng Z, Yu L, Zhang Y, Yuan Y, Lin H, Ma L, Zhang J. Utidelone-based therapy in advanced or metastatic solid tumors after failure of standard therapies: a prospective, multicenter, single-arm trial. Am J Cancer Res. 2024 Sep 15;14(9):4514-4522. doi: 10.62347/OLES9793. eCollection 2024.

    PubMed 39417192

  • Xu B, Sun T, Zhang Q, Zhang P, Yuan Z, Jiang Z, Wang X, Cui S, Teng Y, Hu XC, Yang J, Pan H, Tong Z, Li H, Yao Q, Wang Y, Yin Y, Sun P, Zheng H, Cheng J, Lu J, Zhang B, Geng C, Liu J, Shen K, Yu S, Li H, Tang L, Qiu R; study group of BG01-1323L. Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial. Ann Oncol. 2021 Feb;32(2):218-228. doi: 10.1016/j.annonc.2020.10.600. Epub 2020 Nov 11.

    PubMed 33188874

  • Zhang P, Tong Z, Tian F, Wang Y, Yang J, Li W, Di L, Liu W, Tang L, Qiu R, Xu B. Phase II trial of utidelone as monotherapy or in combination with capecitabine in heavily pretreated metastatic breast cancer patients. J Hematol Oncol. 2016 Aug 11;9(1):68. doi: 10.1186/s13045-016-0297-7.

    PubMed 27516093

  • Zhang P, Sun M, Qiu R, Tang L, Dou G, Xu B. Phase I clinical and pharmacokinetic study of UTD1, a genetically engineered epothilone analog in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Oct;68(4):971-8. doi: 10.1007/s00280-011-1571-6. Epub 2011 Feb 9.

    PubMed 21305287

  • Bollag DM, McQueney PA, Zhu J, Hensens O, Koupal L, Liesch J, Goetz M, Lazarides E, Woods CM. Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res. 1995 Jun 1;55(11):2325-33.

    PubMed 7757983

  • Gerth K, Bedorf N, Hofle G, Irschik H, Reichenbach H. Epothilons A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria). Production, physico-chemical and biological properties. J Antibiot (Tokyo). 1996 Jun;49(6):560-3. doi: 10.7164/antibiotics.49.560.

    PubMed 8698639

  • Hirte H, Kennedy EB, Elit L, Fung Kee Fung M. Systemic therapy for recurrent, persistent, or metastatic cervical cancer: a clinical practice guideline. Curr Oncol. 2015 Jun;22(3):211-9. doi: 10.3747/co.22.2447.

    PubMed 26089720

  • 2021 ESMO 782P - A retrospective study of toripalimab combined with concurrent chemoradiotherapy in patients with recurrent/advanced cervical cancer.Annals of Oncology (2021) 32 (suppl_5): S725-S772. 10.1016/annonc/annonc703.

  • Peng Peng，Hairong Yao，Dantong Liu，et al.Toripalimab combined with bevacizumab and chemotherapy for refractory, recurrent or metastatic cervical cancer: preliminary results of a single-arm, open-label, phaseⅡtrial. 2023 SGO Annual Meeting on Women's Cancer Abstracts, LBA.

  • Wei XL, Ren C, Wang FH, Zhang Y, Zhao HY, Zou BY, Wang ZQ, Qiu MZ, Zhang DS, Luo HY, Wang F, Yao S, Xu RH. A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors. Cancer Commun (Lond). 2020 Aug;40(8):345-354. doi: 10.1002/cac2.12068. Epub 2020 Jun 26.

    PubMed 32589350

  • Tang B, Chi Z, Guo J. Toripalimab for the treatment of melanoma. Expert Opin Biol Ther. 2020 Aug;20(8):863-869. doi: 10.1080/14712598.2020.1762561. Epub 2020 May 14.

    PubMed 32406293

  • Alberts DS, Blessing JA, Landrum LM, Warshal DP, Martin LP, Rose SL, Bonebrake AJ, Ramondetta LM. Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study. Gynecol Oncol. 2012 Dec;127(3):451-5. doi: 10.1016/j.ygyno.2012.09.008. Epub 2012 Sep 14.

    PubMed 22986144

  • An J, Li X, Wang J, Zhu L, An R, Jiang K, Huang Y, Wang K, Li G, Wang C, Yuan J, Hou X, Yang G, Li J, Wang Q, Zhu J, Wu L. Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer: a phase II, single-arm study. Front Immunol. 2023 Apr 21;14:1142256. doi: 10.3389/fimmu.2023.1142256. eCollection 2023.

    PubMed 37153587

  • Tewari KS, Monk BJ, Vergote I, Miller A, de Melo AC, Kim HS, Kim YM, Lisyanskaya A, Samouelian V, Lorusso D, Damian F, Chang CL, Gotovkin EA, Takahashi S, Ramone D, Pikiel J, Mackowiak-Matejczyk B, Guerra Alia EM, Colombo N, Makarova Y, Rischin D, Lheureux S, Hasegawa K, Fujiwara K, Li J, Jamil S, Jankovic V, Chen CI, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Mathias M, Fury MG, Oaknin A; Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med. 2022 Feb 10;386(6):544-555. doi: 10.1056/NEJMoa2112187.

    PubMed 35139273

  • Oaknin A, Gladieff L, Martinez-Garcia J, Villacampa G, Takekuma M, De Giorgi U, Lindemann K, Woelber L, Colombo N, Duska L, Leary A, Godoy-Ortiz A, Nishio S, Angelergues A, Rubio MJ, Farinas-Madrid L, Yamaguchi S, Lorusso D, Ray-Coquard I, Manso L, Joly F, Alarcon J, Follana P, Romero I, Lebreton C, Perez-Fidalgo JA, Yunokawa M, Dahlstrand H, D'Hondt V, Randall LM; ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030 Investigators. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024 Jan 6;403(10421):31-43. doi: 10.1016/S0140-6736(23)02405-4. Epub 2023 Dec 1.

    PubMed 38048793

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Utidelone plus Toripalimab in people with Cervical Cancer and Recurrent, run by Zhongnan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui Qiu, PhD (18986255160, qiuhuiznyy@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Tumor assessments are performed at baseline and every 6 weeks (± 3 days) until progression or start of new therapy. ORR is analyzed after all patients have completed at least 18 weeks of follow-up or experienced a study endpoint event.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363330, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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